Quality Engineer - Medical Device Manufacturing

UFP Technologies, Inc.; Newburyport (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

UFP Technologies, Inc. in Newburyport, MA is seeking a Quality Engineer to support Quality, Manufacturing and R&D in corrective actions, investigations of nonconforming products, process control and product testing in a regulated environment.

The role requires a Bachelor's degree in Quality Assurance, Engineering or Technology, CQE certification preferred, ISO 9001/13485 and AS9100 knowledge, cleanroom experience, and strong SPC skills. On-site position with competitive benefits.

Qualifications

• Bachelor's degree in Quality Assurance, Engineering, or Technology.
• CQE certification is preferred.
• ISO 13485 and 21 CFR Part 820 experience required.
• ISO 9001 or AS 9100 preferred.
• Strong understanding of statistical process control and process capability.
• Cleanroom experience required.
• GD&T knowledge preferred.

Responsibilities

• Supports, upholds and enforces ISO 9001, ISO 13485 and AS9100 regulations.
• Investigates and documents customer returns, complaints and nonconforming products.
• Implements measurable corrective and preventive actions.
• Provides guidance for manufacturing, engineering, materials, customers and suppliers in quality performance.
• Supports product development and production transfer activities.
• Translates product requirements into inspection criteria and process capability.
• Supports QMS internal audits and supplier/customer site audits.

Skills

Quality engineering

Regulatory compliance

Statistical SPC

Cross-functional collaboration

Education

Bachelor's degree in Quality Assurance, Engineering, or Technology

CQE Certification

Tools

GD&T knowledge

cGMP experience

Job description

UFP Technologies, Inc. in Newburyport, MA is seeking a Quality Engineer to support Quality, Manufacturing and R&D in corrective actions, investigations of nonconforming products, process control and product testing in a regulated environment.

The role requires a Bachelor's degree in Quality Assurance, Engineering or Technology, CQE certification preferred, ISO 9001/13485 and AS9100 knowledge, cleanroom experience, and strong SPC skills. On-site position with competitive benefits.